medical Class II Updated 2021-04-14

Fenwal Inc recalls Amicus MNC Apheresis Kit - Double Needle - Product Usage: in

Recalled Product

Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.


Hazard / Issue

Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code X6R2326; UDI: 04086000100144; Batch Numbers FA20E25234 ((Exp. 05/31/2022), FA20F23120 (Exp. 06/30/2022), FA20I21268 (Exp. 09/30/2022), and FA20J19246 (Exp. 10/31/2022).
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →